Dietary oligofructose in the prevention of antibiotic associated diarrhoea in elderly patients

ISRCTN	ISRCTN33188590
DOI	https://doi.org/10.1186/ISRCTN33188590
Secondary identifying numbers	N0544103828

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 06/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Lewis
Scientific

Box No 201A
Department of Gastroenterology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)7669 008 863

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	The purpose of this study is to see if the incidence of antibiotic related diarrhoea in elderly patients can be reduced by increasing colonic bifidobacteria concentrations with the concomitant prescription of oligofructose. Patients for the study will be identified by asking the Medical and Department for the Elderly teams if they had admitted any suitable patients. A brief clinical and drug history would be taken.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive System: Diarrhoea
Intervention	The volunteers would then be randomly allocated to one of two groups. Group A will take a placebo (10 g/day of sucrose powder) or group B 10 g/day of oligofructose. The trial powders will be administered by the ward nursing staff along with the volunteers' normal medication. Volunteers will take the trial powders for the length of time they are taking antibiotics and for a further 7 days after stopping antibiotics. Volunteers will be assessed continuously by recording on a stool form using a four point scale (1 hard, 2 lumpy, 3 mushy and 4 loose) and interdefecatory intervals. Both give an indication of intestinal transit rate. Recordings will be done by the patient or nursing staff as appropriate. The volunteers will be followed up for 7 days after stopping the oligofructose or placebo. The volunteer will have further stool samples sent to be analysed for the presence of Clostridium difficile toxin if they develop diarrhoea during the study. The study's end point is the occurrence of diarrhoea due to Clostridium difficile.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	16/06/2000
Completion date	15/06/2003

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	250
Key inclusion criteria	250 volunteers >65 years old.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/06/2000
Date of final enrolment	15/06/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Box No 201A

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/02/2005		Yes	No